Ethics: The practical nuts and bolts Daniel Nettle Chair, Faculty Ethics Committee Duration 30 mins Housekeeping Questions throughout – however sessions will cover the basics Session is a broad based intro

Ethics at Newcastle All research and consultancy conducted by staff and students at Newcastle University is subject to ethical scrutiny Ethics is open to interpretation but it generally a set of moral principles. Ethics at Newcastle focuses more on professional ethics. Researchers have ethical responsibilities to your colleagues, to yourself (wellbeing and safety) as well as to participants Acting unethically can have a detrimental effect on the participants, the researchers and the University. TGN 1412 (trial autoimmune diseases drug) a phase 1 clinical trial conducted in 2006 by Parexel, an independent clinical trials unit based in London £2000 paid to healthy volunteers, who were given the drug within the span of 1 hr of each other. All ended up in hospital, 1 ended up in a coma and suffered multi-organ failure. Company failed to follow many rules that have since been made standard in Europe. Funders require that the university ensure the ethics and governance if any work it sponsors. Misconduct a dismissible offence.

How do I apply for ethical approval? https://www.ncl.ac.uk/research/researchgovernance/ethics/process/

Applying: The online form Part one: Preliminary questions Apply to NHS research application service More information required: Part two of the form appears Sent to Faculty Ethics Committee (human participants) Sent to AWERB (animal research) Approval immediate: no further scrutiny required

Committee review Animal Welfare Ethics Review Board (AWERB) AWERB serves all faculties and meets monthly. Reviewed by whole committee signed off by Chair. Applicants will generally receive a decision and / or recommendations within two weeks of the meeting. Faculty Ethics Committee Committee works virtually Reviewed by two members and usually asked for revisions Applicants will generally receive recommendations within 20 working days Sign-off is often rapid when applicants have responded to comments. Minor amendments can be sought (usually rapid turnaround)

Being ready for part two of the form If you are referred to part two of the form, we are going to want to see an outline of your project and protocol; consent forms, participant information sheets, possibly materials, etc. Assemble these before you start the process. You can upload attachments. You can save your attempt and come back to it.

Things to think about Do you already have permission under a supervisor’s programme of work? How can you best formulate your application given that plans change? How can you help the committee by providing relevant detail? Do you have a ‘gatekeeper’? Data storage and protection

Contacts Faculty Ethics Committee Marjorie Holbrough (marjorie.holbrough@newcastle.ac.uk) (fmsethics@ncl.ac.uk) AWERB David Baird (david.baird@ncl.ac.uk) Who can help

Questions ?